Application Nr Approved Date Route Status External Links
ANDA090984 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Montelukast Sodium Tablets Are A Leukotriene Receptor Antagonist Indicated For: • Prophylaxis And Chronic Treatment Of Asthma In Patients 2 Years Of Age And Older (1.1). • Acute Prevention Of Exercise-Induced Bronchoconstriction (Eib) In Patients 15 Years Of Age And Older (1.2). • Relief Of Symptoms Of Allergic Rhinitis (Ar): Seasonal Allergic Rhinitis (Sar) In Patients 2 Years Of Age And Older , And Perennial Allergic Rhinitis (Par) In Patients 2 Years Of Age And Older (1.3). 1.1 Asthma Montelukast Sodium Is Indicated For The Prophylaxis And Chronic Treatment Of Asthma In Adults And Pediatric Patients 2 Years Of Age And Older. 1.2 Exercise-Induced Bronchoconstriction Montelukast Sodium Is Indicated For Prevention Of Exercise-Induced Bronchoconstriction (Eib) In Patients 15 Years Of Age And Older. Pediatric Use Information For Patients Ages 6 To 14 Years Of Age For Acute Prevention Of Exercise-Induced Bronchoconstriction (Eib) Is Approved For Merck Sharp & Dohme Corp's Montelukast Tablet Products. However , Due To Merck Sharp & Dohme Corp's Marketing Exclusivity Rights , This Drug Product Is Not Labeled With That Pediatric Information. 1.3 Allergic Rhinitis Montelukast Sodium Is Indicated For The Relief Of Symptoms Of Seasonal Allergic Rhinitis In Patients 2 Years Of Age And Older And Perennial Allergic Rhinitis In Patients 2 Years Of Age And Older.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Montelukast Sodium MONTELUKAST SODIUM ZINC3831151

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